Senior Validations Engineer
The requirements of this role within the wider project are to cover the validation activities with respect to the testing and manufacture of the client's device.
Role/ Responsibilities:
* Develop, and/or approve, validation documentation, including protocol, records, and reports.
* Performing and overseeing process and test method validation activities within the project.
* Execution of process and test method validation activities in association with Operations, Quality Assurance and R&D teams.
* Ensure that all validation activities are carried out and reported in a timely manner and in accordance with the project plan.
* Ensuring compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements in all validation aspects.
* Communicate with all functional groups to ensure awareness of validation requirements.
* Investigate and trouble-shoot validation problems which may occur and determine solutions.
* Communication of validation results and progress to management.
* As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
Qualifications & Experience:
* Bachelors in an engineering, technology or scientific discipline required with 5+ years' experience in the medical device or pharmaceutical industry.
* Prior experience in the design and execution of process and test method validations.
* Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
* Ability to work as part of a team and meet targets/goals efficiently.
* Demonstrated organisational, management and communication skills.
* Good interpersonal & communication skills essential.
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